Sale of Ebopiprant royalty and milestone license to XOMA includes upfront payment of $15 million and future milestone payments of up to $98 millionThe sale proceeds are expected to enable ObsEva to resolve
-PROLONG data demonstrating ebopiprant was well tolerated and showed early evidence of efficacy selected for presentation- - Phase 2b/3 adaptive dose-ranging study planned to initiate in Q4:21-
for Uterine Fibroids
ObsEva is developing Yselty®, an oral GnRH receptor antagonist with the potential to treat more women thanks to its potential best-in-class efficacy, a favorable tolerability profile and unique, flexible dosing options for the treatment of uterine fibroids. Following the European Medicine Agency’s (EMA) recent validation of the marketing authorization application (MAA), a major milestone toward making Yselty® available in the E.U., the Company will continue to work closely with the EMA to achieve marketing approval, projected in Q4:2021.
The second key objective for 2021 will be to submit a U.S. New Drug Application (NDA), projected in Q2:2021, that will include the Week 76 post-treatment follow-up results from the Phase 3 PRIMROSE 1 (US only; n=574) and PRIMROSE 2 (Europe and US; n=535) clinical studies. In both studies, patients with heavy menstrual bleeding (HMB) associated with uterine fibroids were administered Yselty doses of 100 mg or 200 mg, with a